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1.
Prospective, randomized, controlled, noninferiority clinical trial to evaluate the safety and efficacy of absorbable macroporous polysaccharide composites as adjunct to hemostasis during open surgery
Li H, Li Z, He X, Zhang F, OuYang Z, Wu G, Liu P, Yang S, Dong L, Zhen M, et al
Journal of cardiac surgery. 2022
Abstract
BACKGROUND To address intraoperative bleeding in cardiac surgery, reducing blood transfusion requirements, is mandatory to achieve effective hemostasis. Hemostatic agents may limit localized persistent bleeding. The introduction of carboxymethyl-chitosan component into the hemostatic agent and the application of the radiation crosslinking technique maintain its capacity for achieving intraoperative hemostasis, thus increasing the clinical utility. METHODS A prospective, noninferiority and randomized controlled clinical trial to compare the safety and efficacy of absorbable macroporous polysaccharide composites (AMPC, treatment group) with compound microporous polysaccharide hemostatic powder (CMPHP, control group) (2:1 ratio) as adjuncts to hemostasis in open surgery. The main indication was used for hemostasis in various traumatic hemorrhage areas, including cardiothoracic, vascular, and general surgery. The primary endpoint was success rate of hemostasis within 300 s (at a 10% noninferiority margin). The secondary endpoint was hemostasis time. Both endpoints were assessed in the modified intention-to-treat (MITT) population. Safety parameters were assessed. This study is fully compliant with the CONSORT statement. RESULTS Randomized patients in AMPC and CMPHP groups were 168 and 84, respectively. In MITT population, the success rates of hemostasis within 300 s were 98.8% (163 of 165) in AMPC and 94.0% (78 of 83) in CMPHP (treatment difference 4.8% [95% CI -0.57% to 10.20%]). AMPC was thus noninferior to CMPHP. Hemostasis time (median [interquartile range]) with AMPC (87 [52.5, 180] s) was better than CMPHP (110 [54.5, 181] s). Changes in laboratory parameters over time and shifts to abnormal values were typical of surgeries and similar between two groups. No noticeable adverse effects associated with AMPC or CMPHP were observed. CONCLUSIONS AMPC is well tolerated as topical hemostatic agent, noninferior to commercial CMPHP, and exhibits excellent safety. This study provides a novel hemostatic agent which appears to offer significant clinical advantage in various hemorrhage areas.
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2.
Tourniquet use in primary total knee arthroplasty is associated with a hypercoagulable status: a prospective thromboelastography trial
Huang CR, Pan S, Li Z, Ruan RX, Jin WY, Zhang XC, Pang Y, Guo KJ, Zheng X
International orthopaedics. 2021
Abstract
STUDY DESIGN Prospective study. PURPOSE The main purpose of this study was to investigate whether the use of a tourniquet changes the blood coagulation state following primary total knee arthroplasty (TKA) by means of conventional coagulation tests and thromboelastography (TEG) analyses. METHODS A total of 154 patients who underwent primary unilateral TKA from January 2018 to October 2020 were enrolled. Seventy-nine patients were randomized into a tourniquet group, and 75 were randomized into a no-tourniquet group. Demographic data, surgical time, intra-operative blood loss, transfusion rate, and wound complications were collected. Complete blood count, conventional coagulation tests, and TEG were performed the day before surgery, one day after surgery, three days after surgery, and seven days after surgery. Lower extremity Doppler ultrasound was performed the day before surgery and seven days after surgery. RESULTS The baseline characteristics of the patients were similar between the two groups. Hidden blood loss, transfusion rate, and wound complications were similar between the two groups, but the intra-operative blood loss of the tourniquet group was lower than that of the no-tourniquet group. The calculated total blood loss of the tourniquet group was higher than that of the no-tourniquet group. In terms of conventional coagulation tests and TEG, the tourniquet group had higher values of fibrin degradation products, D-dimer, maximum amplitude, and coagulation index (p < 0.001). The incidence of deep vein thrombosis (DVT) in the tourniquet group was higher than that in the no-tourniquet group (21.5% compared with 8%; p = 0.019). CONCLUSION The application of a tourniquet during TKA significantly increases the amount of calculated total blood loss and does not decrease the post-operative transfusion rate. Using a tourniquet in routine TKA exacerbates the early post-operative hypercoagulable status together with a higher incidence of below-knee asymptomatic DVT observed via conventional coagulation tests, TEG, and ultrasonic Doppler.
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3.
Tranexamic Acid versus Epsilon-Aminocaproic Acid in Total Knee Arthroplasty: A Meta-Analysis
Li Z, Sun X, Li W, Zhang M
Journal of healthcare engineering. 2021;2021:1758066
Abstract
OBJECTIVE At present, the effect of tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA) on total knee arthroplasty (TKA) remains controversial. Therefore, the aim of this meta-analysis is to compare the differences between the effects of TXA and EACA in TKA. METHODS We used electronic databases, including PubMed, Embase, MEDLINE, Ovid, ScienceDirect, Cochran Library, Google Scholar, clinical trial, and Chinese related databases, for literature search to find any effect of TXA and EACA in TKA. The differences between groups were compared by odds ratio (OR), weighted mean difference (WMD), and 95% confidence interval (CI). A total of four studies, including 3 randomized controlled trials (RCT) and 1 cohort study, were involved in this meta-analysis, involving 1836 participants. Among these participants, 816 belonged to the TXA group and 1020 belonged to the EACA group. RESULTS Meta-analysis indicated no difference in surgery time (WMD = 0.01, 95% CI -0.35 to 0.36), total amount of blood loss (WMD = 0.14, 95% CI -0.09 to 0.37), transfusion rate (OR = 0.74, 95% CI 0.20 to 2.78), transfusion units per patient (SMD = -0.15, 95% CI -0.54 to 0.25), complications (OR = 0.75, 95% CI 0.37 to 1.55), and length of stay (SMD = -0.01, 95% CI -0.11 to 0.08). CONCLUSIONS Our results suggest that the effect of TXA is not superior to EACA in TKA. However, this conclusion still needs to be further confirmed by multicenter and large-sample clinical trials.
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4.
Hypertension management in elderly with severe intracerebral hemorrhage
Zhao J, Yuan F, Fu F, Liu Y, Xue C, Wang K, Yuan X, Li D, Liu Q, Zhang W, et al
Annals of clinical and translational neurology. 2021;8(10):2059–2069
Abstract
OBJECTIVE To explore the effect of individualized blood pressure (BP)-lowering treatment on the outcomes of elderly patients with severe intracerebral hemorrhage (ICH). METHODS We performed an exploratory analysis of Controlling Hypertension After Severe Cerebrovascular Event (CHASE) trial, which was a multicenter, randomized, controlled clinical trial. Patients with severe ischemic or hemorrhagic stroke (defined as GCS ≤ 12 or NIHSS ≥ 11) were randomized into individualized versus standard BP-lowering treatment in CHASE trial. In this exploratory analysis, patients with severe ICH were included. The primary outcome was the percentage of patients with 90-day functional independence defined as modified Rankin Scale (mRS) ≤2. RESULTS We included 242 patients with severe ICH in the present analysis, consisting of 142 patients aged <65 years and 100 patients aged ≥65 years. There were significant differences between patients aged ≥65 years and <65 years in the proportion of functional independence (47.9% vs. 15.0%, P < 0.001) and good outcome (73.9% vs. 50.0%, P < 0.001) at day 90. In patients aged ≥65 years, the adjusted individualized BP-lowering treatment had an unequivocal effect on the functional independence at day 90 (21.6% vs. 8.2%, odds ratio [OR]: 4.309, 95% confidence interval [CI]: 1.040-17.859, P = 0.044) and improved the neurological deficits at discharge (∆ NIHSS ≥ 4: 64.7% vs. 34.7%, OR: 4.300, 95% CI: 1.599-11.563, P = 0.004). INTERPRETATION Compared with the younger counterparts, the elderly patients (≥65 years) with acute severe ICH might benefit more from individualized BP-lowering treatment.
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5.
Tranexamic acid reduce hidden blood loss in posterior lumbar interbody fusion (PLIF) surgery
Xu D, Chen X, Li Z, Ren Z, Zhuang Q, Li S
Medicine (Baltimore). 2020;99(11):e19552
Abstract
BACKGROUND Posterior lumbar interbody fusion (PLIF) surgery is associated with significant blood loss; however, few studies have focused on hidden blood loss (HBL) in PLIF or its regulatory factors. The purpose of this study was to explore the HBL in PLIF surgery as well as the influence of tranexamic acid (TXA) on blood loss in PLIF. METHODS We performed a randomized controlled trial (RCT) and recruited patients undergoing PLIF into the study from November 2013 to April 2017. All participants were assigned to one of 2 groups according to a simple equal probability randomization scheme. At the end of PLIF surgery, for patients in the TXA group, the surgical field was immersed in TXA (1 g in 100 mL of saline solution) for 5 min before stitching the wound. For the control group, the surgical field was immersed in the same volume of normal saline. RESULTS In our study, the drainage volume during the first 24 h and the total postoperative drainage volume were significantly lower in patients in the TXA group than in the control group (P = .001). The hematocrit (Hct) of the drainage and calculation of blood contained in the drainage showed similar results. The mean length of hospital stay and rate of blood transfusion in the TXA group were less than those in the control group (P < .05). HBL was responsible for 45.6% of the total blood loss in PLIF, and both of the indicators in the TXA group were much lower than those in the control group. CONCLUSIONS PLIF is associated with massive perioperative HBL, but the application of topical TXA leads to less postoperative blood loss including less HBL, a lower blood product transfusion rate, and a shorter hospital stay for PLIF.
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6.
Nonsurgical Secondary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients: A Systematic Review and Network Meta-analysis
Jing L, Zhang Q, Chang Z, Liu H, Shi X, Li X, Wang J, Mo Y, Zhang X, Ma L, et al
Journal of clinical gastroenterology. 2020
Abstract
INTRODUCTION The aim of this study was to evaluate the effectiveness of nonsurgical secondary prophylaxis interventions for esophageal varices (EV) rebleeding in cirrhotic patients using network meta-analysis. MATERIALS AND METHODS Secondary prophylaxis of EV rebleeding in cirrhosis is searched on PubMed, Embase, and the Cochrane Library databases. The quality of literatures was extracted by 2 independent investigators according to the requirements of Cochrane Handbook for Systematic Reviews of Interventions, Version 5.0.0. Meta-analysis was performed on Review Manager 5.3 software for the incidence of cirrhosis EV rebleeding, rebleeding-related mortality, and overall mortality; and STATA 15.1 software was used for network meta-analysis. RESULTS In all, 57 randomized controlled trials were reviewed. Endoscopic band ligation (EBL)+argon plasma coagulation has not been recommended by guidelines, and it is rarely used; the number of existing studies and the sample size are small. Considering poor stability of the combined results, these studies were excluded; 55 literatures were included. In terms of reducing the incidence of rebleeding, transjugular intrahepatic portosystemic shunt (TIPS) surface under the cumulative ranking curve (SUCRA) (94.3%) was superior to EBL+endoscopic injection sclerotherapy (EIS) (84.4%), EIS+β-blockers (77.9%), EBL (59.8%), EBL+β-blockers+isosorbide-5-mononitrate (52.7%), EBL+β-blockers (51.4%), EIS (34.2%), β-blockers+isosorbide-5-mononitrate (23.7%), β-blockers (20.8%), and placebo (0.8%). In reducing rebleeding-related mortality, TIPS SUCRA (87.2%) was more efficacious than EBL+EIS (83.5%), EIS (47.9%), EBL+β-blockers (47.4%), β-blockers (41.8%), EBL (34.5%), and placebo (7.6%). In reducing overall mortality, TIPS SUCRA (81.1%) was superior to EBL+EIS (68.9%), EIS+β-blockers (59.2%), EBL+β-blockers (55.4%), EIS (48.8%), EBL (48.7%), β-blockers (34.2%), placebo (3.6%). CONCLUSIONS TIPS was more effective in reducing the incidence of cirrhosis EV rebleeding, rebleeding-related mortality, and overall mortality in cirrhosis. Combined with the above results, TIPS is more likely to be recommended as a secondary prophylaxis intervention for EV in cirrhosis.
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7.
Clinical Effectiveness of 3 days Preoperative Treatment with Recombinant Human Erythropoietin in Total Knee Arthroplasty Surgery - A Clinical Trial
Cao S, Ren Y, Li Z, Lin J, Weng X, Feng B
QJM : monthly journal of the Association of Physicians. 2019
Abstract
AIMS: The purpose of study is to evaluate the effect and complication of preoperative short-term daily recombinant human erythropoietin (rhEPO) treatment for blood-saving in patients undergoing unilateral primary total knee arthroplasty (TKA). METHODS This three-arm randomized clinical trial compared three different rhEPO-based treatment protocols for unilateral primary total knee arthroplasty. Group A: application of daily doses of rhEPO combined with iron supplement starting 3 days before surgery; Group B: application of daily doses of rhEPO combined with iron supplement starting the day of surgery; Group C: iron supplement alone. Perioperative hemoglobin (Hb) level gaps, total perioperative blood loss, reticulocyte levels and treatment-related complications were studied. RESULTS 102 patients were included (35, 35, and 32 patients in group A, B, and C, respectively). Total blood loss in group A, B, and C was 490.84ml, 806.76ml, and 924.21ml respectively. Patients in group A had a significant lower total blood loss than group B and C (A vs B: P = 0.010; A vs C: P < 0.001). There was no difference as for total blood loss between group B and C (P = 0.377). Group A patients had significant smaller Hb decline than group C on the 3rd and 5th postoperative day (P = 0.049, P = 0.037), as well as than group B on the 5th postoperative day (P = 0.048). There was no difference as for Hb decline between group B and C. No difference was shown in levels of inflammatory biomarkers or blood-saving protocol-related complications among three groups. CONCLUSIONS Daily dose of rhEPO combined with iron supplement administered 3 days before TKA procedures could significantly decrease perioperative blood loss and improve postoperative Hb levels, without significantly elevating risks of complication, when compared with admission of rhEPO on the day of surgery and iron supplement alone. Preoperative daily rhEPO treatment could be a more effective blood-saving protocol in TKA procedures.
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8.
Efficacy and Safety of Tranexamic Acid for Controlling Bleeding During Surgical Treatment of Intertrochanteric Fragility Fracture with Proximal Femoral Nail Anti-rotation: A Randomized Controlled Trial
Luo X, He S, Lin Z, Li Z, Huang C, Li Q
Indian journal of orthopaedics. 2019;53(2):263-269
Abstract
Background: Intertrochanteric fragility fracture (IFF) treated with proximal femoral nail anti-rotation (PFNA) is associated with significant hidden blood loss and high blood transfusion rate. The purpose of the present study was to evaluate the efficacy and safety of tranexamic acid (TXA) in reducing blood loss in these patients. Materials and Methods: Consecutive eligible patients were recruited and randomly assigned to a TXA group or a control group. The TXA group received 15 mg/kg body weight of TXA intravenously 15 min before incision and the same dose 3 h later. The control group received 100 mL of saline intravenously 15 min before incision. The efficacy outcomes included the total perioperative blood loss, postoperative transfusion rate, postoperative hemoglobin level, and length of the hospital stay. The safety outcomes were the incidence of thrombotic events and the mortality rate within 6 weeks after surgery. Results: We had 44 patients in the TXA group and 46 patients in the control group for the final analysis. The TXA group had significantly lower total perioperative blood loss than the control group (384.5 +/- 366.3 mL vs. 566.2 +/- 361.5 mL; P < 0.020). Postoperative transfusion rate was 15.9% in the TXA group versus 36.9% in the control group (P = 0.024). Each group had one patient with postoperative deep venous thrombosis. In the control group, three patients had cerebral infarction, and one patient died within 6 weeks after the operation. Conclusion: Intravenous TXA is effective in reducing total perioperative blood loss and transfusion rate in IFF treated with PFNA. No increased risk of thrombotic events was observed with the use of TXA; however, this study was underpowered for detecting this outcome. Further research is necessary before TXA can be recommended for high-risk patients.
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9.
Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial
Macdougall IC, Strauss WE, Dahl NV, Bernard K, Li Z
Clinical nephrology. 2019
Abstract
BACKGROUND Patients with chronic kidney disease (CKD) undergoing dialysis often require intravenous iron for iron deficiency anemia (IDA). MATERIALS AND METHODS The Ferumoxytol for Anemia of CKD Trial (FACT), a randomized, multicenter, open-label, phase 4 study, compared the long-term safety and efficacy of ferumoxytol with iron sucrose for the treatment of IDA in patients with CKD undergoing hemodialysis. Patients with IDA and CKD undergoing hemodialysis were randomized 2:1 to ferumoxytol 1.02 g (2 x 510 mg) or iron sucrose 1.0 g (10 x 100 mg) for a 5-week treatment period (TP). Over 11 months, patients underwent additional 5-week TPs whenever IDA (hemoglobin < 11.5 g/dL and transferrin saturation < 30%) was detected. The primary efficacy endpoint was mean change in hemoglobin from baseline to week 5 for each TP. Adverse events were recorded during the study. RESULTS Overall, 293 patients received ferumoxytol (n = 196) or iron sucrose (n = 97). Ferumoxytol was noninferior to iron sucrose regarding hemoglobin change from baseline to week 5. The mean change in hemoglobin in the ferumoxytol and iron sucrose groups was 0.5 and 0.4 g/dL, respectively, in TP 1 (least-squares mean difference, 0.13; 95% confidence interval, -0.11 to 0.36) and 0.6 and 0.3 g/dL, respectively, in TP 2 (0.30; 0.06 - 0.55). Treatment-related and serious adverse events were similar in both groups; no new safety signals emerged. CONCLUSION Long-term administration of ferumoxytol has noninferior efficacy and a similar safety profile to iron sucrose when used to treat IDA in patients with CKD undergoing hemodialysis..
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10.
Intravenous administration of tranexamic acid significantly reduces visible and hidden blood loss compared to its topical administration for double-segment posterior lumbar interbody fusion: A single-center, placebo-controlled, randomized trial
Mu X, Wei J, Wang C, Ou Y, Yin D, Liang B, Qiu D, Li Z
World Neurosurgery. 2018
Abstract
STUDY DESIGN A single-center, placebo-controlled, randomized design. OBJECTIVE The current study investigated the effects of intravenous and topical administrations of Tranexamic acid (TXA) on the visible and hidden blood loss of patients receiving posterior lumbar interbody fusion (PLIF). SUMMARY of Background Data: TXA significantly reduces the visible and hidden blood loss associated with joint replacement. At present, many studies have examined the safety and effectiveness of the intravenous or topical administration of TXA after posterior lumbar surgery. However, randomized and controlled trials examining the presence of differences in the effect of TXA on the visible and hidden blood loss between these two modes of administration are lacking. METHODS A total of 150 patients with lumbar degenerative disease who underwent PLIF between September 2015 and August 2017 volunteered for this study. Of these patients, 126 fulfilled the inclusion criteria and were randomly assigned to one of three groups: the intravenous administration group (n = 45, group A), the topical administration group (n = 39, group B), or the placebo group (n = 42, group C). SPSS 17.0 was used to analyze the patient data, their blood biochemical indices, blood loss, and the number of blood transfusions across the three groups during the perioperative period. RESULTS The postoperative drainage volume, number of blood transfusions, length of hospital stay, and extubation time significantly differed between group C and both groups A and B (P < 0.05); however, no significant differences were noted between groups A and B (P > 0.05). Intraoperative blood loss and visible or hidden blood loss as well as the levels of postoperative hemoglobin (HGB) and hematocrit (HCT) significantly differed among the three groups (P < 0.01). The results of the visual analogue scale (VAS), prothrombin time (PT), and fibrinogen (FIB) content did not significantly differ among the three groups (P > 0.05). CONCLUSIONS For patients undergoing double-segment PLIF, both administrations of TXA can reduce blood loss, extubation time, and the length of hospital stay. Moreover, intravenous administration can reduce both visible and hidden blood loss more efficiently.